Belzer UW Cold Storage Solution recallZ-2237-2019 · Santanello Surgical LLC · initiated Jun 10, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Santanello Surgical LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Lack of package integrity may compromise sterility
FDA root cause category: Package design/selection
What the company is doing
Santanello Surgical issued recall letter dated 6/10/19 stating reason for recall, health risk and action to take: immediately examine inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Email [email protected] for return shipment procedures and reimbursement process. Questions call Santanello Surgical at 614-955-1832.
Recall details
- Recall number
- Z-2237-2019
- Status
- Terminated
- Initiated by the company
- Jun 10, 2019
- Recalling firm
- Santanello Surgical LLC
- Quantity
- 98
- Product code
- JOL
- Distribution
- FL,OK, OH, NY, ME, MN, WI
Product description
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
Code information (models, lots, serial numbers)
Lot: SAN1003 UDI: (01)00810805000026(10)SAN0003(17)160205
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Belzer UW Cold Storage Solution BUW-500Preservation Solutions Inc · System, Perfusion, Kidney1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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